Tadalafil Tablets (Pulmonary Hypertension)

What is this medication?

TADALAFIL (tah DA la fil) treats pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It works by relaxing your blood vessels and lowering the blood pressure in your lungs, which makes it easier for your heart to pump blood to the rest of your body. It can also help you breathe easier and be more active.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Adcirca, ALYQ

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
• Heart disease, angina, a history of heart attack, irregular heart beats, or other heart problems
• High or low blood pressure
• Kidney disease
• Liver disease
• Pulmonary veno-occlusive disease (PVOD)
• Stomach ulcers
• Stroke
• An unusual or allergic reaction to tadalafil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take this medication with or without food. Take your medication at regular intervals. Take both tablets at the same time, one after the other. Do not split your dose throughout the day. Do not take it more often than directed. Do not stop taking except on your care team's advice.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• Other medications for erectile dysfunction like avanafil, sildenafil, vardenafil
• Other tadalafil products (Cialis)
• Riociguat

This medication may also interact with the following:

• Certain medications for high blood pressure
• Certain medications for the treatment of HIV infection or AIDS
• Certain medications used for fungal or yeast infections, like fluconazole, itraconazole, ketoconazole, and voriconazole
• Certain medications used for seizures like carbamazepine, phenytoin, and phenobarbital
• Grapefruit juice
• Macrolide antibiotics like clarithromycin, erythromycin, troleandomycin
• Medications for prostate problems
• Rifabutin, rifampin or rifapentine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Do not change the dose of your medication without asking your care team. Call your care team if your medication is not working for you. This may be a sign that your condition has become worse.

If you notice any changes in your vision while taking this medication, call your care team as soon as possible. Stop using this medication and call your health care provider right away if you have a loss of sight in one or both eyes.

For males, contact you care team right away if an erection lasts longer than 4 hours or if it becomes painful. This may be a sign of serious problem and must be treated right away to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain, or arm pain after taking this medication, you should discuss the episode with your care team as soon as possible.

Do not drink more than 4 alcohol-containing drinks in a short period of time when taking this medication. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Hearing loss or ringing in ears
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Prolonged or painful erection
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden vision loss in one or both eyes

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Facial flushing or redness
• Headache
• Muscle pain
• Runny or stuffy nose
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.